Shots:

• The P-III study evaluates zavegepant (IN) vs PBO in 1405 adult patients with migraine at 94 sites in the US
• The P-III study meets its co-primary EPs of pain freedom (24% vs 15%) & freedom from the bothersome symptom (40% vs 31%) @ 2hrs. & showed ultra-rapid pain relief as early as 15min. & sustained efficacy @48hrs. after a single IN dose. The therapy showed superiority over PBO across 15 prespecified primary & secondary outcome measures, favorable safety & tolerability profile that was consistent with prior clinical trial
• The company plans to file an NDA for zavegepant with the US FDA in Q1’22, based on P-II/III trial results. If approved, it will be 1st CGRP receptor antagonist for migraine

Ref: Biohaven | Image: Biohaven